CO2MPACT
CO2MPACT EVALUATION KIT. The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a…
CO2MPACT EVALUATION KIT. The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | FCX |
| Device type | Insufflator, Automatic Carbon-Dioxide For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K111648 |
| Record published | 2016-09-17 |
| Record revised | 2020-03-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 75 % RH; Storage environment temperature 0 to 70 °C |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71040D | In distribution | |
| 710300 | In distribution | |
| 710300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Us Endoscopy | 15 |
| Fujifilm | Fujifilm Corporation | 5 |
| Irrigator/Insufflator | Pentax of America, Inc. | 5 |
| DIN 477 High Pressure Hose for CO2 | Bracco Diagnostics, Inc. | 3 |
| East Coast Surgical Instruments | East Coast Surgical Inc. | 3 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Richard Wolf Gmbh | 3 |
| Endoscopic CO2 Regulation Unit | Olympus Medical Systems Corp. | 3 |
| Protocol Touch Colon Insufflator | Bracco Diagnostics, Inc. | 3 |
| Protocol Accessory Cart | Bracco Diagnostics, Inc. | 2 |
| High Pressure Hose and Yoke | Bracco Diagnostics, Inc. | 2 |
| Cylinder Hose | Olympus Medical Systems Corp. | 2 |
| Protocol Administration Set With Flexi-Cuff Retention Tip | Bracco Diagnostics, Inc. | 2 |
Showing 12 of 38. All products under Insufflator, Automatic Carbon-Dioxide For Endoscope
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Northgate Technologies Inc. | 510(k) number | 2021-01-15 | Class II | Nonconforming Material/Component | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. | 45 units | 2022-10-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.